Alvelestat for Bronchiolitis Obliterans Syndrome

Phase 1 & 2

Recruiting

Led By Steven Z Pavletic, M.D.

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Received prior treatment with specific regimen for at least 3 months prior to enrollment

Age ≥18 years

Must not have

Non-alcoholic fatty liver disease or use of associated drugs for more than 2 weeks in the year prior to screening

Prior use of neutrophil elastase inhibitors

Timeline

Screening 3 weeks

Treatment Varies

Follow Up phase 1b: baseline, 8 wees. phase 2: baseline, 3 months and 6 months (end of treatment).

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug, alvelestat (MPH966), to see if it's safe and effective in treating bronchiolitis obliterans syndrome (BOS). BOS is a complication people can experience after hematopoietic stem cell transplant.

Who is the study for?

Adults over 18 who've had a stem cell transplant and suffer from chronic graft versus host disease (cGVHD) with Bronchiolitis Obliterans Syndrome (BOS). They must have been treated for cGVHD, have certain lung function test results, stable organ/marrow function, and agree to contraception. Excluded are those with recent malignancy treatments, uncontrolled illnesses, pregnancy/breastfeeding, prior neutrophil elastase inhibitors use or significant alcohol consumption.

What is being tested?

The trial is testing alvelestat (MPH966), which may inhibit neutrophil elastase that's thought to contribute to BOS after stem cell transplants. It involves two parts: varying doses over cycles up to 4 months followed by the best dose for up to a year. Participants will undergo extensive monitoring including lung/heart tests and bronchoscopy.

What are the potential side effects?

While not explicitly listed in the provided information, potential side effects of alvelestat could include typical drug reactions such as digestive issues, liver problems given its exclusion criteria related to liver health; heart complications considering ECG requirements; and possibly respiratory symptoms due to its focus on lung conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been on a specific treatment for at least 3 months before joining.

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I am 18 years old or older.

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I have been diagnosed with BOS based on specific criteria.

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I can care for myself but may need occasional help.

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I have had a stem cell transplant and suffer from moderate to severe chronic GVHD.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have non-alcoholic fatty liver disease or have been on related medication for over 2 weeks in the last year.

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I have used neutrophil elastase inhibitors before.

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My cancer has come back or gotten worse and needs treatment.

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I have a history of liver problems, including cirrhosis or swelling in my abdomen.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ phase 1b: baseline, 8 wees. phase 2: baseline, 3 months and 6 months (end of treatment).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~phase 1b: baseline, 8 wees. phase 2: baseline, 3 months and 6 months (end of treatment).

This trial's timeline: 3 weeks for screening, Varies for treatment, and phase 1b: baseline, 8 wees. phase 2: baseline, 3 months and 6 months (end of treatment). for reporting.